Informatics System for Adverse Events in Cancer

Recruiting at 1 trial location

Overseen By Danielle Bitterman, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Brigham and Women's Hospital

Must be taking: Immuno-oncology therapeutics

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Immunotherapies have improved cancer outcomes, but have a unique profile of immune-related adverse events (irAEs). Biorepositories have been established to collect data and samples to help improve our understanding of irAEs, however identifying patients who are eligible for these biorepositories in a timely fashion can be challenging. The goal of this study is to determine if an informatics system for automated irAE detection can improve registration to a prospective irAE biorepository (NCT04242095). The informatics system automatically "reads" participants' electronic health records (EHRs) and determines whether that patient may be experiencing an irAE. The main questions it aims to answer are: * Is it feasible to implement an informatics system for daily analysis of EHR data to detect irAEs? * Does the automated irAE detection system improve registration rates to an irAE biorepository at our institution following an eligible irAE? Researchers will compare standard irAE monitoring to informatics-assisted irAE monitoring to see if using the informatics system increases the registration rate and improves data entry efficiency and quality. Participants will: * Be randomly assigned to standard monitoring or informatics-assisted monitoring for irAE detection. * Have their EHR reviewed to collect demographic, medical, and cancer treatment history. * Be monitored for irAEs through daily automated analysis of their EHR data for up to 12 months or until registration in the biorepository.

Are You a Good Fit for This Trial?

This trial is for individuals with uterine tumors or cancer who are currently receiving or have received immunotherapy. The study aims to improve how quickly and accurately patients experiencing immune-related side effects are added to a biorepository that collects health data.

Inclusion Criteria

I am receiving or have received cancer treatment that includes immunotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility Run-in

Initial feasibility run-in with the first 10-20 patients to establish the feasibility of the informatics system

2 months

Monitoring

Participants are monitored for irAEs through daily automated analysis of their EHR data

12 months

Follow-up

Participants are monitored for safety and effectiveness after the main monitoring phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Informatics system for eligibility monitoring

Trial Overview The study tests if an informatics system, which automatically checks electronic health records, can better detect immune-related adverse events compared to standard monitoring. It evaluates the feasibility of this system and its impact on registration rates into a biorepository.

How Is the Trial Designed?

Group I: Standard monitoring Experimental Treatment 1 Intervention

Standard irAE monitoring for an eligible registration event.

Group II: Informatics-assisted monitoring Experimental Treatment 2 Interventions

Informatics-assisted monitoring plus standard monitoring

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+